Medtronic Takes a Critical Step Towards Developing An Artificial Pancreas

November 3rd, 2011

Medtronic, a world leader in diabetes management systems, including insulin pumps and continuing glucose monitoring systems, has taken a critical step towards its goal of developing an artificial pancreas. The FDA has granted them an Investigational Device Exemption to allow the company to conduct in-home clinical trials of its MiniMed closed loop insulin delivery system. Here is the press release from Medtronic:

MINNEAPOLIS, Oct 28, 2011 - In our continued commitment to develop an artificial pancreas, Medtronic, Inc. today announced FDA approval of its Investigational Device Exemption to conduct a pivotal in-home clinical trial protocol for the ASPIRE study of the MiniMed Paradigm(R) System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronic's ASPIRE study the first in-home pivotal trial of a closed loop system for Type 1 diabetes management.

"This study leads an industry-wide effort to close the diabetes treatment loop by tackling the important challenge of reducing the risk of hypoglycemia even when a person is asleep or unable to react," said David Klonoff, Medical Director of the Diabetes Research Institute at Mills-Peninsula Health Services. "The new Low Glucose Suspend integrated system is designed to help improve patients' ability to manage nocturnal hypoglycemia, which can be one of the most frightening aspects of living with Type 1 diabetes. Until now, we have never had a therapy designed to automatically intervene when blood glucose becomes severely low."

"FDA approval of the ASPIRE in-home study is an important milestone toward bringing Low Glucose Suspend technology to the U.S. market," said Dr. Francine Kaufman, Chief Medical Officer and Vice President of Global Clinical Affairs for the Diabetes business of Medtronic. "It's also a critical step toward our ultimate goal -- the development of an artificial pancreas. We believe this innovation has the potential to provide patients with added protection by lowering the risks associated with nocturnal hypoglycemia."

This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronic's newest continuous glucose sensor, the Enlite(TM) sensor, will be tested as part of the overall system.

ASPIRE will compare hypoglycemic events in a treatment arm with the LGS ON to a control arm that has the LGS OFF in the actual use environment and by the intended use population with Type 1 diabetes. The first study objective is to demonstrate that home use of LGS is safe and is not associated with glycemic deterioration, as measured by a change in HbA1C. The second study objective is to demonstrate that home use of LGS is associated with a reduction in nocturnal hypoglycemia when patients fail to respond. Hypoglycemia is a common occurrence and concern in diabetes management and can result in confusion, unresponsiveness and -- in severe cases -- even death.

"FDA review of the ASPIRE IDE application was conducted through an interactive review process that involved frequent communication with the FDA review team, allowing issues to be resolved quickly and avoiding any unnecessary delays during the review. We appreciate the valuable input provided by members of the FDA's Artificial Pancreas Working Group," added Dr. Kaufman.

Medtronic's MiniMed Paradigm(R) REAL-TimeRevel(TM) System, currently available in the United States, is the second generation of the only insulin pump integrated with continuous glucose monitoring (CGM) cleared by the FDA. With the addition of LGS, Medtronic has designed a first-of-its-kind semi-closed loop system that not only features insulin delivery and CGM, but also advanced software algorithms that enable the Low Glucose Suspend automation.

Low Glucose Suspend works by automatically suspending basal insulin delivery temporarily if glucose levels become too low as defined by the patient and his or her healthcare provider. It is a feature available commercially in Medtronic's Paradigm(R) Veo(TM) System in more than 50 countries outside of the United States. The CGM-integrated system and Low Glucose Suspend automation are the first key steps towards the creation of an artificial pancreas.

Hypoglycemia can be one of the most frightening aspects of living with diabetes. Research has indicated that, on average, a person with diabetes will experience more than one low blood glucose event every two weeks. In addition, each year nearly one in 14 people with insulin dependent diabetes will experience one or more episodes of severe hypoglycemia.

The Diabetes Business at Medtronic is a world leader in advanced diabetes management solutions, including integrated diabetes management systems, insulin pump therapy, continuous glucose monitoring systems and therapy management software, as well as world-class, 24/7 expert consumer and professional service and support.

Eating Too Quickly Doubles the Risk of Insulin Resistance

November 8th, 2011

Yet another reason to listen to your mother and slow down and chew your food properly - eating too quickly has been associated with a doubled risk of developing impaired glucose tolerance, or pre-diabetes. As the name suggests, pre-diabetes is the forerunner to developing type 2 diabetes. Most diabetics have type 2 diabetes - a form of diabetes where your body no longer responds properly to insulin (called insulin resistance). Type 2 diabetes used to be described as non insulin dependent diabetes.

Insulin is the hormone that moves sugar (glucose) from the blood to the body's cells to provide them with energy. If your cells do not use insulin properly, the pancreas produces more insulin that normal to cope with the body's demands. Eventually, the pancreas cannot keep up, and excess glucose builds up in the bloodstream. Type 2 diabetes is characterized by high levels of glucose in the blood.

A recent Japanese study followed over 170 healthy individuals for three years, monitoring their eating habits. Snacking, eating late at night, skipping meals and eating out were not associated with developing pre-diabetes. The one and only eating habit associated with the development of insulin resistance was eating too quickly.

The researchers aren't sure why eating faster makes an individual more likely to develop pre-diabetes and type 2 diabetes, but suspect that eating rapidly results in higher post-meal blood glucose levels. Some doctors also point out that eating too quickly results in an overall increase in the amount of calories taken in. Since it takes about 20 minutes for the brain to receive the signal that the stomach is full, those who eat quickly continue eating without realizing that their stomach is filled.

Previous research has also shown that eating quickly results in increased weight gain. Insulin resistance generally increases with increased body fat, and there is a pronounced connection between obesity and diabetes. The two are so closely connected that it gave rise to the term "diabesity". Diabesity is currently epidemic across the developed world.

Insulin resistance has no symptoms. Pre-diabetes is sometimes called impaired glucose tolerance, and can be diagnosed with a fasting glucose test or a glucose tolerance test. The American Diabetes Association recommends that adults who are overweight and have one or more additional risk factors for diabetes should consider being tested. Additional risk factors include:

  • Having a parent or sibling with diabetes
  • Being physically inactive.
  • Being African American, Alaska native, American Indian, Asian American, Hispanic or Latino, or a Pacific Islander
  • Giving birth to a baby weighing more than 9 pounds or being diagnosed with gestational diabetes
  • Having high blood pressure or being treated for high blood pressure
  • Low HDL ("good") cholesterol levels or high triglyceride levels
  • Having polycystic ovary syndrome
  • Having a history of cardiovascular disease

People with pre-diabetes can avoid becoming diabetic and the need to take diabetes medication by losing weight, being physically active, eating a healthy diet, and, as we now know, not eating too quickly.

Diabetes and Gastroparesis Linked

November 15th, 2011

Many people with diabetes suffer from gastroparesis, or slow stomach emptying. As a matter or fact, diabetes is the most common cause of gastroparesis. That's because chronic high blood glucose levels can damage the vagus nerve - which controls the movement of food down through the digestive tract.

In a double whammy, gastroparesis can make diabetes worse by making blood glucose control more difficult. When food that has been delayed in the stomach finally enters the small intestine and is absorbed, blood glucose levels rise. Since gastroparesis makes stomach emptying unpredictable, a person's blood glucose levels can be erratic and difficult to control - a diabetic's nightmare.

How do you self-treat gastroparesis? The simplest and healthiest option is to change your eating habits. Eat six small meals a day instead of three large ones to prevent the stomach from becoming overly full. Avoid high-fat and high-fiber foods, as fat naturally slows digestion and fiber is difficult to digest. If you have gastroparesis, carbonated beverages are also not your friend. In more severe cases, a liquid or pureed diet may be required for awhile.

If a dietary adjustment isn't providing the relief from gastroparesis you need, there is a medicinal option in the form of prescription domperidone. Doctors prescribe domperidone for gastroparesis and other digestive ailments across the world. Both generic domperidone, and its equivalent name brand Motilium, have been available in Canada for many years.

To learn more about which basic dietary guidelines for gastroparesis, and to watch a video explaining the disease and the connection between diabetes and gastroparesis on, >Click Here<.

Gestational Diabetes Overview with

November 29th, 2011

Gestational diabetes mellitus (GDM), it is one of the most complicated condition during women's pregnancy. Do not be panic; it is a temporary form of diabetes that is first diagnoses in a pregnant woman. It occurs in about 3 to 8 percentage of pregnant women and it will improve or disappear after birth.

Risk Factors

Any women may develop gestational diabetes, but some women are at high risks. Risk factors for GDM include:

  • If you are over 35
  • If you have high blood pressure
  • You are obese
  • You've had a gestational diabetes in previous pregnancy
  • You've previously give birth to a big baby

Causes, Diagnosis and Test

Gestational diabetes is caused when the body of a pregnant woman is not able to make enough insulin. It is the result of hormonal changes, increased sugar level and weight gain. All the pregnant women should have a glucose-screening test between 24 and 28 weeks. Women who have risk factors of GDM may have the test earlier in the pregnancy.

Most women are recommended to have a glucose screening test (also called a glucose challenge test or GCT). Another more definitive exam called glucose tolerance test (GTT) is available to find out if you may have a problem.


Pregnant women who suffer from GDM will have the similar symptoms of type 1 and 2 diabetes, including:

  • Frequent urination
  • Increase d hunger
  • Nauseas
  • Skin or vaginal infections
  • Vision problems
  • Weight gain or fatigue

Prevention and Treatment

Gestational diabetes cannot be prevented in some women especially who are likely to develop. But you are able to lower your risk and change of getting gestational diabetes during pregnancy. Treatment for gestational diabetes during pregnancy includes:

  • Check blood sugar levels
  • Eating healthy food
  • Monitor fetal growth
  • Regular or moderate exercise
  • Take insulin therapy if necessary

Insulin is the primary medication used to treat gestational diabetes. Insulin injectionis only used in rare cases of insulin resistance. Most women who have gestational diabetes usually give birth to healthy babies.